drugset

drugset / Trial / NCT00418626

Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

NCT00418626 ↗

Phase 1 Completed 27 enrolled Novartis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

This study will be a formal assessment of the impact of hepatic function impairment on the pharmacokinetics of nilotinib

Timeline

Start: 2006-11
Primary completion: 2007-09
Completion: —

Publications

Yin OQ, Gallagher N, Tanaka C, Fisher D, Sethuraman V, Zhou W, Lin TH, Heuman D, Schran H. Effects of hepatic impairment on the pharmacokinetics of nilotinib: an open-label, single-dose, parallel-group study. Clin Ther. 2009;31 Pt 2:2459-69. doi: 10.1016/j.clinthera.2009.11.015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nilotinib	Small molecule	200 mg	Oral

Indications

No indication recorded.